Table 5.
Quality of life (QOL) between arm results
| Quality of life measurements | Basivertebral nerve ablation arm (n=66) | Standard CareArm (n=74) | LS mean difference between arms | P-Value |
| Baseline SF-36 (PCS) | n=66 | n=74 | ||
| Mean, SD (Range) | 32.1, 6.8 (18.4–46.9) | 32.1, 7.4 (17.2–47.6) | 0.95* | |
| 3 Month SF-36 (PCS) | N=64† | N=51† | ||
| Mean, SD (Range) | 45.6, 9.7 (22.3–60.8) | 33.6, 7.2 (14.9–50.8) | ||
| Mean change from baseline, SD | 13.5, 9.0 | 2.2, 6.2 | ||
| LS Mean change (95% CI) | 13.6 (11.8 to 15.5) | 2.1 (0.0 to 4.1) | 11.6 (8.8 to 14.4) | <0.001‡ |
| 6 Month SF-36 (PCS) | n=61† | n=70§ | ||
| Mean, SD (Range) | 45.8, 9.7 (26.4–59.9) | 33.9, 7.1 (20. 9–54.9) | ||
| Mean change from baseline, SD | 13.3, 9.8 | 1.9, 7.1 | ||
| LS Mean change (95% CI) | 13.4 (11.5, 15.4) | 1.8 (0.0, 3.6) | 11.7 (9.0, 14.3) | <0.001‡ |
| Baseline SF-36 (MCS) | n=66 | n=74 | ||
| Mean, SD (Range) | 53.4, 9.5 (22.2–69.8) | 52.4, 9.4 (29.4–69.4) | 0.54* | |
| 3 Month SF-36 (MCS) | N=64† | N=51† | ||
| Mean, SD (Range) | 56.2, 7.3 (31.9 to 67.6) | 50.3, 11.4 (17.6 to 66.2) | ||
| Mean change from baseline, SD | 2.3, 6.8 | −2.4, 9.6 | ||
| LS Mean change (95% CI) | 2.5 (0.7 to 4.4) | −2.7 (-4.7 to –0.6) | 5.2 (2.4 to 8.0) | <0.001‡ |
| 6 Month SF-36 (MCS) | N=61† | N=70§ | ||
| Mean, SD (Range) | 55.1, 8.4 (23.3–69.8) | 49.0, 11.6 (21.6–66.3) | ||
| Mean change from baseline, SD | 1.4, 9.5 | −3.7, 9.4 | ||
| LS Mean change (95% CI) | 1.6 (-0.7 to 3.8) | −3.9 (-6.0 to –1.8) | 5.5 (2.4 to 8.5) | <0.001‡ |
| Baseline EQ-5D-5L | n=66 | n=74 | ||
| Mean, SD (Range) | 0.61, 0.13 (0.27–0.83) | 0.61, 0.13 (0.25–0.83) | 0.89* | |
| 3 Month EQ-5D-5L | N=65† | N=51† | ||
| Mean, SD (Range) | 0.79, 0.13 (0.46–1.00) | 0.63, 0.13 (0.35–0.83) | ||
| Mean change from baseline, SD | 0.18, 0.15 | 0.02, 0.13 | ||
| LS Mean change (95% CI) | 0.18 (0.15 to 0.21) | 0.02 (-0.02 to 0.05) | 0.16, (0.12 to 0.21) | <0.001‡ |
| 6 Month EQ-5D-5L | N=61† | N=70§ | ||
| Mean, SD (Range) | 0.81, 0.14 (0.50–1.00) | 0.61, 0.14 (0.28–0.86) | ||
| Mean change from baseline, SD | 0.19 0.16 | −0.00, 0.13 | ||
| LS Mean change (95% CI) | 0.19 (0.16 to 0.22) | −0.01 (-0.04 to 0.02) | 0.20, (0.15 to 0.24) | <0.001‡ |
Secondary outcome measures for this study included the difference in LS mean change in quality of life (QOL) measures of Short Form-36 (physical and mental component summaries) and the EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L) between the basivertebral nerve (BVN) ablation arm and the standard care arm. Significant differences were observed in all QOL measurements between the study arms at 3 and 6 months.
*P value from a two-sample t-test with a factor of treatment group. Testing between randomized arms.
†As observed, with no imputation for missing data.
‡Estimates and p value from an ANCOVA with a factor of treatment group and a covariate of baseline score.
§Standard care control arm 6 months as last attended (median follow-up of 176.5 days).
EQ-5D-5L, EuroQual Group 5 Dimension 5-Level Quality of Life; LS, least squares; MCS, Mental Component Summary; PCS, Physical Component Summary; QOL, quality of life; SF, Short Form.